D-0178-2017 Class II Terminated

Recalled by North American Rescue LLC. — Greer, SC

Recall Details

Product Type
Drugs
Report Date
December 14, 2016
Initiation Date
September 27, 2016
Termination Date
March 9, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue

Reason for Recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Distribution Pattern

Nationwide, Australia & Switzerland

Code Information

Kit Part # 85-0742 Kit Lot # 85-0742071816; Kit Part # 85-0748 Kit Lot # 85-0746061016; Kit Part # 85-0745 - Kit Lot # 85-0745042516; Kit Part # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639090716, 85-0639080116, 85-0639091316; Kit Part # 85-0744 - Kit Lot # 85-0744072516, 85-0744060916, 85-0744052516; Kit Part # 85-0741- Kit Lot # 85-0741071416